My own contribution is here, with less science and more snark:
Please leave your comments there or here, it doesn’t matter.
How to report adverse reactions to supplements
30 JunI have often complained that no one seems to be interested in collecting adverse event data from alternative medical treatments. For example, one child who was a test case in the Omnibus Autism Proceeding (the vaccine court) appears to have reacted very negatively to chelation. We only heard about this because the Omnibus proceeding. DAN and other organizations do not seem to be collecting or reporting on adverse events.
I have often read adverse reactions to alternative therapies in online forums. No one seems to consider reporting those.
In searching for information on supplements, I did find this FDA site for reporting adverse reactions.
There is an online form, MedWatch Online Voluntary Reporting Form (3500), which can be used to report adverse events.
I can not find a database comparable to VAERS which has the data from these reports compiled for view. Since I have never read of anyone reporting their bad reaction to an alternative medical treatment, I doubt whatever database the FDA is keeping is very complete.
Another Hero Of The Anti-Vaccine Movement Bites The Dust
29 JunSo says Steven Salzberg in a Forbes blog post, Another Hero Of The Anti-Vaccine Movement Bites The Dust. Prof. Salzberg is referring to the recent FDA warning letter sent to Mr. Haley about his product, OSR#1. The FDA has warned Mr. Haley that his “supplement” meets the criteria for a drug and the testing involved indicates that there may be serious side effects.
Prof. Salzberg introduces Mr. Haley as a “hero of the antivaccine movement” for his outspoken positions on mercury, especially on thimerosal and autism. Prof. Salzberg poses and answers his own question:
Is Haley simply a confused chemist who fails to understand epidemiological evidence? Or does he have another agenda?
Well, he does: money.
The rest of the piece does not go favorably for Mr. Haley.
Given that piece, I decided to check the website for OSR #1. Mr. Haley has apparently not responded to the FDA formally as of yet but has responded on his website:
Why did the FDA send CTI Science, Inc. a warning letter about OSR#1®?
The FDA sent CTI Science, Inc. a warning letter dated June 17, 2010. They state that OSR#1® is not a dietary supplement because N1, N3-bis(2-mercaptoethyl)isophthalamide is not a known dietary ingredient. However, N1, N3-bis(2-mercaptoethyl)isophthalamide is a combination of two dietary ingredients, benzoate and cystamine coupled together by an amide linkage which is naturally found in proteins coupling amino acids together. The FDA further states that CTI Science, Inc. makes drug claims on its packaging, website and promotional material. CTI Science, Inc. does not believe that the claims it previously made about OSR#1® were drug claims. However, all claims the FDA referenced in its letter were removed from the website. The FDA further states that there may be a safety issue with regard to OSR#1®, because diarrhea was experienced in animal subjects when fed OSR#1® dissolved in corn oil by gavage three times daily at a rate of 5g per kg body weight. This would be the equivalent of 500g for a 220lb person or 5,000 capsules plus a bolus of corn oil. CTI Science, Inc. does not believe this diarrhea is a toxic effect as the animals continued to gain weight like controls and did not develop any toxic effects like ataxia. Using this definition any food, like milk, would be toxic if taken at such a high level.
The Company is evaluating the FDA letter and preparing its response
Now I am not a former chemistry professor, but a few points in the above statement struck me as odd.
First, he notes that his product is the combination of two dietary ingredients. Well, if the resulting chemical isn’t found in foods, isn’t that the real definition of “dietary ingredient”? It doesn’t matter what the source materials are. Heck, can’t you have synthetic sources of “dietary ingredients”? It is the end product, not the source materials that count.
Second, he hasn’t addressed all the issues that the FDA brought up in the warning letter.
However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia
Hair loss, “abnormalities of the pancreas”, “lymphoid hyperplasia”. Those are not mentioned on the OSR website.
Third, ” Using this definition any food, like milk, would be toxic if taken at such a high level.”. Did Mr. Haley just make a “the dose makes the poison” argument in his defense? Many people promoting the idea that mercury causes autism have rejected the “dose makes the poison” idea, claiming that any amount of mercury is toxic.
Back to Prof. Salzberg’s post. One observation: Forbes magazine is taking on the alternative medical community and their “treatments” for autism, at least in this one case. But take a look at the tags attached to the piece: “antivaccinationist, Autism, Boyd Haley, chelation, mercury, pseudoscience, thimerosal, vaccines”. Ouch.
Evaluation of a Records-Review Surveillance System Used to Determine the Prevalence of Autism Spectrum Disorders.
28 JunPerhaps the most well-known statistics about autism come from the CDC’s autism surveillance project. The Autism and Developmental Disabilities Monitoring (ADDM) Network is a multi-state operation coordinated by the CDC. Their reports are the source of the “1 in 166”, “1 in 150” and “1 in 100” numbers one hears in the press and elsewhere. The Netweork looks at children’s medical records, educational records and sometimes both sets of records and make determinations of which children have autism spectrum disorders (ASD’s). This allows the Network to monitor large numbers of children. But they don’t actually test each child,bringing up questions of how accurate are the prevalence numbers.
A CDC team has looked into this question (actually, questions) in a recent paper:
Evaluation of a Records-Review Surveillance System Used to Determine the Prevalence of Autism Spectrum Disorders.
Nonkin Avchen R, Wiggins LD, Devine O, Van Naarden Braun K, Rice C, Hobson NC, Schendel D, Yeargin-Allsopp M.Developmental Disabilities Branch, Centers for Disease Control and Prevention, 1600 Clifton Road, MS E-92, Atlanta, GA, 30333, USA, ravchen@cdc.gov.
AbstractWe conducted the first study that estimates the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of a population-based autism spectrum disorders (ASD) surveillance system developed at the Centers for Disease Control and Prevention. The system employs a records-review methodology that yields ASD classification (case versus non-ASD case) and was compared with classification based on clinical examination. The study enrolled 177 children. Estimated specificity (0.96, [CI(.95) = 0.94, 0.99]), PPV (0.79 [CI(.95) = 0.66, 0.93]), and NPV (0.91 [CI(.95) = 0.87, 0.96]) were high. Sensitivity was lower (0.60 [CI(.95) = 0.45, 0.75]). Given diagnostic heterogeneity, and the broad array of ASD in the population, identifying children with ASD is challenging. Records-based surveillance yields a population-based estimate of ASD that is likely conservative
If you are looking for a glossary for these terms, one can be found here.
Sensitivity: Proportion of persons with condition who test positive
Specificity: Proportion of persons without condition who test negative.
Positive Predictive Value (PPV): Proportion of persons with positive test who have condition
Negative Predictive Value (NPV): Proportion of persons with negative test who do not have condition.
The methods used scored well in specificity, positive predictive value and negative predictive value. What was somewhat lacking is sensitivity–proportion of people who test positive. Many children with ASD’s are not captured by the methods used, suggesting that the estimates by the CDC are likely low.
What would be very interesting to see would be how the sensitivity has varied over time. Is part of the rise in the CDC’s autism prevalence estimates due to changes in sensitivity? Could the records be getting better as a result of the autism awareness campaigns over the last 10 or more years?
National Council on Disability Newsletter, June 2010
28 JunI received the Newsletter for the National Council on Disability via email this morning:
Message from the Chairman:
I am truly honored to have been appointed by President Obama as Chairman of the National Council on Disability (NCD). I am delighted to be joined by seven new Members whose nominations were also confirmed by the U.S. Senate this Spring and our continuing Members appointed by President Bush. To learn more about our Members, please visit: http://www.ncd.gov/newsroom/members/members.htm.
This is the first newsletter of my chairmanship and as such I am actively seeking your input and advice to make NCD more transparent, participatory, and collaborative in implementing the public policy mandate found in NCD’s authorizing statute.
My primary objective is to build a solid foundation for NCD to carry its work into the future and that means being able to coordinate and collaborate effectively across the Federal Government, with state and local governments, and with a variety of stakeholders within the disability community. We are at a critical juncture. There is no longer any mystery about the broad policy objectives for people with disabilities. The uncertainties regard concrete and actionable steps toward implementing our policy objectives. Absent effective leadership and coordination, we will continue to fall short both in improving the lives of people with disabilities and in stabilizing our nation’s fiscal health.
To be an effective agent, NCD must actively engage with the community it was created to serve. Accordingly, NCD will be aggressive, creative, and steadfast in identifying ways to be transparent about its activities and to solicit input from all interested stakeholders. NCD’s engagement will also need to be timely and relevant. NCD will strive to help set the agenda where it can, but our greatest impact will frequently be on issues and topics for which there are windows of opportunity. We need to ensure that NCD is aware of these windows and how best to tailor and present its recommendations so that they make a real difference in advancing disability policy objectives.
I welcome and value your feedback on the Council’s activities, including what you want in future newsletters and communications with the public. The Council is embarking on a new era and we want to reach out to you in this open invitation for suggestions on everything we’re doing. You are our stakeholders and we depend on you to let us know how we can better serve the community. I encourage you to share your thoughts, ideas, and general comments. You can email NCD at ncd@ncd.gov. There is much work to be done and your feedback is key.
Sincerely,
NCD_signaature02.png
Jonathan Young
In the News
Congressional Testimony
On June 15th, Chairman Young had the privilege of testifying before the Subcommittee on Emergency Communications, Preparedness and Response on “Caring for Special Needs during Disasters: What’s being done for Vulnerable Populations.” His testimony can be found at: http://www.ncd.gov/newsroom/news/2010/HS_Subcomm_Young_Testimony_FINAL.htm. The purpose of this hearing was to receive testimony on the actions taken by FEMA, non-profits, and localities to address the needs of vulnerable populations, including people with disabilities, the poor, children, and persons with limited English proficiency, during disasters.
National Summit on Disability Policy 2010
Since Chairman Young’s confirmation he has been immersed in preparation for NCD’s National Summit on Disability Policy, which will take place at the Renaissance Washington, DC Hotel, 999 9th Street, NW, Washington, DC, July 25–28, 2010.
The Summit’s cross-cutting theme of Living, Learning & Earning is designed to launch a national dialogue on disability policies and programs in the 21st century. As the invited guests gather in Washington, DC to celebrate the 20th anniversary of the signing of the ADA, we want to begin substantive discussions about the future of disability policies and programs and promote extensive collaboration at all levels of government and among all stakeholders. The Summit now includes an additional half-day, post-Summit discussion session on July 28, where NCD will reflect on the Summit’s proceedings and entertain additional stakeholder input.
White House Launches Celebration Of 20th Anniversary Of Americans With Disabilities Act
On June 8th Valerie Jarrett, Senior Advisor to President Obama, kicked off the White House’s celebration of the 20th Anniversary of the Americans with Disabilities Act, delivering remarks to over 2,000 people from around the world at the VSA International Festival at the Kennedy Center. Read Ms. Jarrett’s full remarks at http://www.whitehouse.gov/blog/2010/06/08/white-house-launches-celebration-20th-anniversary-americans-with-disabilities-act
FCC ADA Anniversary Celebration
As part of its continuing effort to develop and implement consumer-focused policies, including disabilities access, the Federal Communications Commission (FCC) will begin its year-long celebration of the 20th Anniversary of the ADA on Monday, July 19, 2010. The event will be held in the afternoon, in the Commission Meeting Room. The event will include the following:
•Launch of the Commission’s Accessibility and Innovation Forum
•Announcement of FCC initiatives concerning disability access
•Technology Expo of emerging communications equipment and services
•Debut of a video documenting first-person testimonials on disability access
•Performances by Gallaudet University students
Additional information about the event will be released at a later date. The celebration is free and the public is encouraged to attend. Pre-registration is encouraged, but not required. To pre-register or request accommodations, please send an E-mail to: Pam.Gregory@fcc.gov, or call (202) 418-2498 voice; (202) 418-1169 TTY.
NCD Vice Chair Fernando Torres-Gil Addresses Aging
On May 27, NCD Vice Chair Fernando Torres-Gil, Ph.D., provided the keynote address at the 2010 Area 1 Agency on Aging’s “Celebration of Seniors” luncheon and awards ceremony in Eureka, California.
Read the entire advance story from the May 25 Eureka Times-Standard at http://www.times-standard.com/lifestyle/ci_15156690.
NCD Board Member Gary Blumenthal Discusses Center Closure
On May 20, NCD Board Member Gary Blumenthal’s guest column on closing a local developmental center appeared in the Waltham, Massachusetts, Daily News Tribune.
Read the entire column about the closure of Fernald Developmental Center at http://www.dailynewstribune.com/opinions/columnists/x258107902/Fernald-closure-saves-money.
On May 30, the Boston Globe published a letter to the editor by Mr. Blumenthal that discusses the benefits of community-based settings.
The letter can be found at http://www.boston.com/yourtown/sudbury/articles/2010/05/30/disabled_can_find_opportunities_in_the_community/.
Federal Medical Assistance Percentages
On June 7, NCD Chairman Jonathan Young sent a letter to Senate Majority Leader Harry Reid and Senate Minority Leader Mitch McConnell urging swift action in providing a six-month extension of the enhanced Federal Medical Assistance Percentages contained in the Senate-passed American Workers, State, and Business Relief Act of 2010 (H.R. 44213) but omitted from the American Jobs and Closing Tax Loopholes Act passed by the U.S. House of Representatives.
Anniversary of Olmstead v. L.C.
June 22 marked the 11th anniversary of the landmark 1999 U.S. Supreme Court decision in Olmstead v. L.C., in which the Court held that the unjustified institutional isolation of people with disabilities is a form of unlawful discrimination under the ADA.
Since that time, progress has been made. Many individuals have successfully transitioned to community settings, but waiting lists for community services have grown considerably and many individuals who would like to receive community services are not able to obtain them.
NCD believes that continued implementation of Olmstead is of paramount importance to the nation as demographics shift toward older Americans, and is one of the top priorities of the disability community.
CMS Announcement
Our partners at the Centers for Medicare and Medicaid Services (CMS) made a recent announcement that we believe will be of interest to you:
CMS State Medicaid Directors Letter # 10-008 issued May 20, 2010, entitled “Re: Community Living Initiative,” which reminded states of their obligations to implement the Olmstead decision, reported on recent progress made as a part of the Community Living Initiative and highlighted resources and guidance to help states in their compliance efforts.
You can download a PDF of the CMS State Medicaid Directors Letter from http://www.cms.gov/smdl/downloads/SMD10008.pdf.
The Affordable Care Act
A blog, entitled “What the Affordable Care Act Means for Americans with Disabilities” by Henry Claypool, Director of Office on Disability, U.S. Department of Health and Human Services, was posted on May 21, 2010, at http://www.healthreform.gov.
To read the entire blog, please go to http://www.healthreform.gov/forums/blog/disabilities.html.
ODEP Announces National Disability Employment Awareness Month Theme
On May 13, the U.S. Department of Labor’s Office of Disability Employment Policy unveiled the official theme for October’s National Disability Employment Awareness Month: “Talent Has No Boundaries: Workforce Diversity INCLUDES Workers With Disabilities.” The theme serves to inform the public that workers with disabilities represent a diverse and vibrant talent pool for hire.
To read the full announcement, please go to http://www.dol.gov/opa/media/press/odep/ODEP20100630.htm.
FCC and FEMA Announce Workshop on 21st Century Emergency Alerting: Leveraging Multiple Technologies to Bring Alerts and Warnings to the Public
On June 10, the Federal Communications Commission’s Public Safety and Homeland Security Bureau and the Federal Emergency Management Agency’s (FEMA’s) National Continuity Programs held a workshop on 21st Century Emergency Alerting: Leveraging Multiple Technologies to Bring Alerts and Warnings to the Public.
This meeting was important to people with disabilities because emergency warnings still do not adequately reach people with disabilities during disasters. Most disaster warnings broadcast via conventional media avenues only, which may not be accessible to people with hearing or vision disabilities.
For more information, please see the full announcement at http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC-298198A1.txt.
About the National Council on Disability Newsletter
The Newsletter, which is also available on the Council’s website at www.ncd.gov, brings you the latest issues and news for people with disabilities. To subscribe to the NCD listserv, go to http://listserv.access.gpo.gov, click on online mailing list archives, select NCD-NEWS-L, then join or leave the list, and finally, complete the short subscription form.
Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal
24 JunThe story broke yesterday that Dr. Boyd Haley has been given a warning letter by the FDA about his chelating product, OSR #1. The FDA has warned Dr. Haley that his own safety tests indicate the possibility for adverse reactions and that since the substance is not found in any food or mineral, it is not a “supplement” as he markets it, but a drug. Drugs require much higher standards of proof of safety.
One could make an easy bet that the Age of Autism blog, which has helped tout the drug/supplement OSR, would come to Dr. Haley’s defense. The way they went about this is quite surprising to me. In Chicago Tribune Protecting Consumers Against Natural Supplement (Again), the Age of Autism writes:
CTI Science got a letter from the FDA about its ingredients. They will respond. Dr. Weil got a similar letter last year when he dared to offer an immune support formula in place of the H1N1 vaccine. Drug companies get the letters every day of the week for their advertising claims. You think 50,000 people in America even know what OSR is? They will now.
Yes–the letter from the FDA is no big deal. One of their favorite alternative medical practitioners got one last year, and the pharmaceutical companies get them too. While it isn’t mentioned in the AoA piece, Dr. Weil appears to have ignored the warning letter without any repercussions as no response has been recorded.
Yes, “you don’t have to respond to the FDA’s letters” appears to be a valid excuse to the Age of Autism.
There is a major difference between the warning letters sent to Dr. Haley and Dr. Weil. Dr. Haley’s letter shows that his own safety data, data not previously made public from what I can see, indicates the drug he is selling has the potential to cause adverse reactions. Dr. Weil appears to be only making claims of efficacy which he can’t back up. Only.
And, yes, big companies flout the FDA letters too. Merck, a giant pharmaceutical company, has one warning letter. One. That’s for Vioxx. Merck didn’t respond. That didn’t exactly go well for them, did it?
The full warning letter to Dr. Weil is quoted below.
TO XXXXXXXXX
http://www.drweil.comFROM: The Food and Drug Administration and the Federal Trade Commission
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and
Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus
DATE: October 15, 2009
WARNING LETTER
This is to advise you that the United States Food and Drug Administration (“FDA”) and the United States Federal Trade Commission (“FTC”) reviewed your website at the Internet address http://www.drweil.com on October 13, 2009. The FDA has determined that your website offers a
product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.This product is your Immune Support Formula. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.
In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.
Some examples of the claims on your website include:
On a webpage entitled, “The Swine Flu – H1N1 ,” with the subtitle “Swine Flu and You”:
“[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider. .. the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms ….”
On a product webpage describing the Immune Support Formula:
“The Immune Support Formula contains astragalus. . . . Astragalus … is used traditionally to ward off colds and flu and has been well studied for its antiviral and immunity-enhancing properties.”
“Th[e] synergistic combination of immune modulators [found in the Immune Support Formula] is especially useful for those who tend to get every bug that goes around during the winter.”
On the same webpage, under “Supplement Facts,” describing the Astragalus supplement (which is one element of the Immune Support Formula):
“Astragalus … is … used traditionally to ward off colds and flu, and has demonstrated both antiviral and immune-boosting effects in scientific investigation.”
On the website’s home page, DrWeil.com:
“Worried About Flu? Dr. Weil’s Immune Support Formula can help maintain a strong defense against the flu. It contains astragalus, a traditional herb that boosts immunity. Buy it now in one click, and start protecting your immune system against flu this season.”
On the Dr. Weil Vitamins – Daily Vitamin Packs webpage:
“[L]earn more about Dr. Weil’s Immune Support Formula, which contains astragalus – an herb Dr. Weil recommends to help ward off colds and flu.”
The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national
security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus-related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.You should take immediate action to ensure that your firm is .not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA’s implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm’s violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.
FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning marketing unapproved, uncleared and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at http://www.accessdata.fda.gov/scripts/h1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be’ updated to indicate that your firm has taken appropriate corrective action.
If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be an unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Kathleen Lewis at 301-436-2148.
It is also your responsibility to ensure that the products you market are in compliance with the FTC Act. FTC staff strongly urge you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. The FTC also asks that you notify it via electronic mail at flu@ftc.gov within 48 hours of the specific actions you have taken to address the agency’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Karen Jagielski at 202-326-2509.
Very truly yours,
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission/S/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Whooping cough epidemic declared in California
24 JunThe largest whooping cough numbers in 50 years (over 900 confirmed cases throughout the state of California) has resulted in five deaths of Latino children under five years old. Public health officials declared an epidemic today as a result.
The announcement came after authorities noticed a sharp spike in reports of pertussis, the scientific name for whooping cough, which often is mistaken for a cold or the flu and is highly contagious. All told, 910 cases have been confirmed, with several hundred more under investigation. If the pace keeps up, the outbreak could be the largest in the state in 50 years, the California Department of Public Health reported.
Dr. Gilberto Chavez, the deputy director of the department’s Center for Infectious Disease, said health officials had seen a fourfold increase compared with 2009. And the worst may be to come.
“The peak season starts in the summer,” Dr. Chavez said, noting that July and August usually have the highest number of cases. “And we expect to see a much larger number of cases if we don’t intervene quickly.”
For five families, however, the state’s warning has come too late. Five children — all Latino and all under the age of 3 months — have died since the beginning of the year, Dr. Chavez said.
Vaccinate your kids. Please.
FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug”
24 Jun“OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns”. So starts a recent article in the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.
The article is by Trine Tsuderos who has previously reported on the the industrial chelator turned dietary supplement in Industrial chemical OSR#1 used as autism treatment.
According to the website for the product, “OSR#1® is a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level”. According to the story in the Tribune, the claim of “toxicity free” may not be accurate. According to the Tribune story:
The FDA letter lists side effects recorded during Haley’s animal studies: “soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas” and a rapid increase in normal cells contained in the lymph nodes.
Here is that section of the letter in full:
However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects.
Mr. Haley is not unused to criticism of his so-called supplement. After the previous story by the Tribune, Boyd Haley tweeted multiple times “Contrary to the Chicago Tribune implication, OSR1 has undergone extensive safety testing. The truth is at http://www.OSR1.com. Please retweet!” When I checked the OSR website, I could find no mention of these test results–the results Boyd Haley himself submitted to the FDA. Is that the “truth”?
The Tribune quotes Ellen Silbergeld, a John’s Hopkins researcher:
“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”
and
Silbergeld said the product represents a clear example of endangerment of public health and that the FDA should stop CTI Science from selling it immediately. She drew a comparison to a city’s drinking water system: If contamination is found, she said, “they turn off the pumps.”
“They don’t have to engage in a long discussion with you,” Silbergeld said. “It would be hard to imagine a more clear example of immediate endangerment of public health. Turn off the pump.”
Kim Stagliano, Managing Editor of the Age of Autism blog, has touted OSR #1 in the past. She was quoted in the Tribune article:
In an e-mail, Stagliano wrote that she continues to support Haley, a regular speaker at autism recovery conferences. “Having met Dr. Haley at conferences, including Autism One in Chicago last month, I continue to trust his science,” she wrote on Wednesday. “I’m sure CTI Science will address the letter appropriately.”
There doesn’t seem to be any mention of the fact that Prof. Haley appears to have withheld safety information from the autism community. She “trusts his science”, yet makes no mention of the fact that it is precisely “his science” that indicates that this chemical is toxic.
The warning letter from the FDA is quoted below:
WARNING LETTER CIN-10-107927-14
Boyd E. Haley, President
CTI Science, Inc.
2430 Palumbo Drive, Suite 140
Lexington, Kentucky 40509Dear Mr. Haley:
This letter concerns your firm’s marketing of the product OSR#1 on your website, http://www.ctiscience.com.This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.
Your website includes claims such as the following:• “OSR#1® … helps maintain a healthy glutathione level.”
• “Both OSR#1® and glutathione scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity.”
The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.
Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.
Your website includes the following statements: “Thyroid conditions, hypertension, and diabetes: Because thyroid conditions, hypertension, and diabetes have been associated with low glutathione levels …” and “OSR#1® … helps maintain a healthy glutathione level.” These statements suggest that OSR#1 is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because thyroid conditions, hypertension, and diabetes are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, OSR#1’s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). OSR#1 is not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that its labeling bear adequate directions for use because OSR#1 lacks an approved application.
Additionally, under section 502(a) of the Act, 21 U.S.C. § 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act, 21 U.S.C. § 321(n), provides that, “in determining whether a drug’s labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ….” Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).
Because the labeling does not warn consumers of the above-mentioned potential for side effects, the product OSR#1 is also misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that the labeling lacks adequate warnings for the protection of users. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §§ 331(a).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j) if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the products’ labeling.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237, Attention: Stephen J. Rabe, Compliance Officer.
A description of the new drug approval process can be found on FDA’s internet website at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.Sincerely,
/s/
Teresa C. Thompson
Cincinnati District
This story is being discussed at Countering Age of Autism as FDA Steps Up to the Plate on OSR#1.
Addenda:
CTI solicited charitable donations to help get started through the CTI Science Foundation, which includes “Katie Wright, Julie Obradovic, Dr. Jerry Kartzinel, Dr. Julie Buckley, Scott Barli and Kathryn Wachsman”
Kim Stagliano discussed previous Tribune stories and the question of toxicity of OSR in another piece
I was contacted by Ms. Tsouderos for an interview about her forthcoming article on a supplement called OSR from CTI Science. CTI’s Science’s FAQ page says OSR is less toxic than aspirin and Vitamin E. If the Tribune has its own toxicity testing, I’m sure readers will be interested in seeing the data. In light of the skewing of parental interviews in the past, I chose not to respond to her requests for an interview. Others, like the founder of CTI Science, Dr. Boyd Haley, graciously allowed the interview process to continue until such time as it became clear that the writer’s goal precluded gaining meaningful insight.
It appears to this reader that perhaps it was CTI Science and Boyd Haley who may have kept the readers from obtaining “meaningful insight”. If a reporter asks about toxicity and you have data showing hair loss, discolorations, and “abnormalities of the pancreas, and lymphoid hyperplasia” shouldn’t you produce that data?
Ari Ne’eman’s previous work with the National Council on Disability
23 JunAri Ne’eman has been appointed as a full member of the National Council on Disability. With that announcement came some criticism of the appointment, including comments on this blog indicating that Mr. Ne’eman’s doesn’t have the experience necessary to serve.
Given that, I thought I would share a couple of things I found on the NCD’s website. I was searching for an announcement of the Senate confirmation of his appointment. What I found was a surprise to me: Mr. Ne’eman has been working with the NCD since 2007 in the Youth Advisory Council.
This recent announcement acknowledges some of Mr. Ne’eman’s work bringing together a coalition of disability organizations:
Advisory Committee Member Achievement
NCD’s Youth Advisory Committee policy workgroup leader, Ari Ne’eman (NJ), received recent accolades for his successful leadership of advocacy work that mobilized the broader disability community on an international scale. In his thank-you note to the 22 disability rights organizations and countless individuals whose combined efforts resulted in withdrawal of an ad campaign depicting people with disabilities in a negative way, Ari noted “this is a victory for inclusion, for respect and for the strength and unity of people with disabilities across the world” (www.autisticadvocacy.org).
Mr. Ne’eman was a leader of the NCD’s Youth Advisory Council policy workgroup starting in 2007.
With its charter renewed until October 2009, NCD’s YAC met on November 15, 2007, after welcoming seven new members, new officers (Amy Doherty-chair; Carly Fahey -vice chair; Matt Cavedon -Secretary), procedural workgroup leaders (Ari Ne’eman-Policy; Daman Wandke-Outreach and Networking), and mentors (Stephanie Orlando and Miranda Pelikan). The committee reported topics and issues of interest such as aversives and restraints, healthcare accessibility, expanding ways of gathering youth and young adult perspectives, and planning to make a new proposal to NCD about disability history awareness-raising. We welcome aboard in FY2008 Jesutine Breidenbach (MN), Brett Cunningham (OK), Paul Fogle (PA), Eddie Rea (CA), Nicole Schneider (FL), Nathan Turner (OH), and Bryan Ward (DE). YAC meets again on January 17, 2008, at 4:00 p.m. EST. Please e-mail your questions about YAC to Dr. Gerrie Hawkins
Maybe it is time to give Mr. Ne’eman credit for years of service and welcome him to the NCD?
ASAN Update on NCD Confirmation
23 JunI received this email update this morning. I wrote a brief piece about the appointment yesterday.
This is another ASAN Update for bloggers in the Autistic and disability rights communities. The Autistic Self Advocacy Network would like to thank President Obama and the U.S. Senate for the nomination and confirmation of ASAN President Ari Ne’eman to serve as a member of the National Council on Disability (NCD). He will be the first Autistic person to serve as a member of NCD. An independent federal agency, NCD makes recommendations to the President and Congress on issues of importance to Americans with disabilities. To learn more about NCD, go to http://www.ncd.gov
An article about the confirmation can be found on Disability Scoop:http://www.disabilityscoop.com/2010/06/22/neeman-confirmation/9133/
As always, we encourage you to contact us with your comments, and please let us know if you would prefer to receive these announcements at a different address or to be removed from the list.
Best regards,
Meg Evans, Director of Community Liaison
Autistic Self Advocacy Network
Left Brain Right Brain 
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